ReVIVOL-XR
- Product NDC
- 43749-432
- 11-digit product format
- 437490432
- Labeler code
- 43749
- Product ID
- 43749-432_39db2684-3085-e26e-e063-6394a90ae422
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Unipack LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-01
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 6.25 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ReVIVOL-XR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43749-432-01 | ReVIVOL-XR | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | | 2 |
| 43749-432-01 | ReVIVOL-XR | 24 in 1 CARTON | SUPPOSITORY | 24 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43749-432 | REVIVOL-XR (PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [UNIPACK LLC] | 1 | Current NDC, 2 package rows | 20250418_2950fe83-a2a4-4ed4-b645-69d6fd2381ae.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43749-432-01 | 43749043201 | 24 BLISTER PACK in 1 CARTON (43749-432-01) / 1 SUPPOSITORY in 1 BLISTER PACK | 24 blister pack | 2025-04-01 | No | No | Historical |